Tinnitus, SubjectiveNCT03425045
Repetitive Transcranial Magnetic Stimulation for Chronic Subjective Tinnitus
A study testing Repetitive Transcranial Magnetic Stimulation and Ginkgo Biloba Extract in people with Tinnitus, Subjective, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
Therapy of subjective chronic primary tinnitus could be challenging. Repetitive transcranial magnetic stimulation (rTMS) is currently being tested for suppressing the symptoms. However, effect of stimulation remains controversial. The aim was to uncover real effect of rTMS stimulation for tinnitus treatment. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation and Ginkgo Biloba Extract
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Mar 2015to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjective chronic non-pulsatile tinnitus lasting more than 6 months
Who cannot join
- head injury or brain surgery
- epilepsy
- organic brain lesion
- Meniere's disease or fluctuating hearing loss
- cochlear or bone-anchored hearing device implantation
- history of suicide
Show all 12Show fewer
- pregnancy
- therapy with anticonvulsants
- antipsychotic medication
- heart pacemaker implantation
- rTMS performed in the past
- not signing of the informed consent
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
About this study
Official title: Repetitive Transcranial Magnetic Stimulation for Chronic Subjective Non-Pulsatile Primary Tinnitus Compared to Placebo and Medicament Therapy
Therapy of subjective chronic primary tinnitus could be challenging. Repetitive transcranial magnetic stimulation (rTMS) is currently being tested for suppressing the symptoms. However, effect of stimulation remains controversial. The aim was to uncover real effect of rTMS stimulation for tinnitus treatment. There will be three groups, stimulation group, sham stimulation group and controlled group with medicament treatment. The investigators assume that combination of rTMS stimulation of dorsolateral prefrontal cortex and primary auditory cortex at both sides will be more efficient. The investigators considered a 10% improvement in the tinnitus questionnaire score and in the tinnitus masking to be clinically relevant.
Read the detailed description
Adult patients suffering from chronic subjective non-pulsatile primary unilateral or bilateral tinnitus for at least 6 months will be included in the study. Patients will be randomly assigned using a random number generation randomization method into rTMS stimulation group (group 1), sham stimulation group (group 2) and group with medicament therapy only (group 3). Dorsolateral prefrontal cortex (frequency 25 Hz; 300 pulses; 80% resting motor threshold=RMT) and primary auditory cortex on both sides (1 Hz; 1000 pulses; 110% RMT) will be stimulated in patients in rTMS stimulation group for 5 consecutive days. Both the patients and outcome assessor were blinded to the intervention group in which the patients (rTMS and shame stimulation group) belonged to. Medicament therapy in group 3 will consist of ginkgo biloba extract EGb 761 once a day for 6 months. There will be no medicament therapy for tinnitus in group 1 and 2. Tinnitus reaction questionnaire (TRQ), tinnitus handicap questionnaire (THQ), tinnitus handicap inventory (THI), Beck Depression Inventory (BDI), pure-tone audiometry with Fowler scoring of hearing loss and tinnitus analysis will be used for evaluation of tinnitus in all patients. Data will be recorded on the day patient is included in the study, during follow-up after 1 month and 6 months. Descriptive statistics, such as the arithmetic mean, standard deviation, and absolute and relative frequency tables, will be used for data processing. The Pearson's chi-squared test, Fisher's exact test, Kruskal-Wallis test and analysis of variance will be used for comparison. The statistical tests will be assessed using a significance level of 5%.
- Conditions
- Tinnitus, Subjective
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Sham stimulation, Ginkgo Biloba Extract
- Keywords
- chronic tinnitus, repetitive transcranial magnetic stimulation, hypacusion, depression, treatment, placebo, medication therapy
- Medical subject headings
- Tinnitus, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationProcedure or surgery
Patients randomised in Arm 1 will receive stimulation of the dorsolateral prefrontal cortex (frequency 25 Hz; 300 pulses; 80% resting motor threshold=RMT) and primary auditory cortex on both sides (1 Hz; 1000 pulses; 110% RMT) will be stimulated in patients in rTMS stimulation group for 5 consecutive days. No medication therapy will be provided for patients in this arm.
Sham stimulationProcedure or surgery
Sham stimulation will be performed in patients randomised in Arm 2 of the study for 5 consecutive days. No medication therapy will be provided for patients in this arm.
Ginkgo Biloba ExtractDrug
Patients randomised in Arm 3 of the study will receive medication therapy with Ginkgo biloba extract EGb 761 once a day for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | Experimental | Patients in this study arm will undergo the rTMS stimulation as described above. Receives: Procedure: Repetitive Transcranial Magnetic Stimulation |
| Sham stimulation | Sham comparator | Patients in this study arm will undergo the sham stimulation as described above. Receives: Procedure: Sham stimulation |
| Ginkgo Biloba Extract | Active comparator | Patients in this study arm will receive medication therapy as described above, without any rTMS or sham procedure. Receives: Drug: Ginkgo Biloba Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Reaction Questionnaire (TRQ)
This questionnaire will be used to find out what sort of effects tinnitus has had on the lifestyle and general well-being of the patients. 10% improvement will be considered clinically relevant.
Measured: 36 months
Tinnitus Handicap Questionnaire (THQ)
This questionnaire has 27 questions and will be used to assess the degree of handicap that the tinnitus presents for the affected patients. 10% improvement will be considered clinically relevant.
Measured: 36 months
Tinnitus Handicap Inventory (THI)
The purpose of this questionnaire is to identify difficulties the affected patients may be experiencing because of tinnitus. 10% improvement of the score will be considered clinically relevant.
Measured: 36 months
Secondary outcomes (2)
Improvement of depression - Beck Depression Inventory
Improvement of depressive symptoms in patients will be assessed using the Beck Depression Inventory (BDI) test.
Measured: 36 months
Improvement of hearing loss - Fowler scoring
Improvement of the hearing loss in patients will be assessed using the pure-tone audiometry with Fowler scoring of hearing loss (%).
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start1 Mar 2015
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is designed as interventional, blinded, randomized, controlled trial with three parallel arms
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michal Bar, Ass.Prof.,MD,PhD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425045
- Sponsor's protocol ID
- FNO-ENT-tinnitus
- Other IDs
- MH CZ-DRO (FNOs/2015)
- Status last verified
- Jun 2018
- First submitted
- 15 Jan 2018
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share IPD to other researchers has not been decided yet.
Publications
Folmer RL, Carroll JR, Rahim A, Shi Y, Hal Martin W. Effects of repetitive transcranial magnetic stimulation (rTMS) on chronic tinnitus. Acta Otolaryngol Suppl. 2006 Dec;(556):96-101. doi: 10.1080/03655230600895465.
PubMed 17114152Oberman L, Edwards D, Eldaief M, Pascual-Leone A. Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. J Clin Neurophysiol. 2011 Feb;28(1):67-74. doi: 10.1097/WNP.0b013e318205135f.
PubMed 21221011Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5.
PubMed 25034472Kim BG, Kim DY, Kim SK, Kim JM, Baek SH, Moon IS. Comparison of the outcomes of repetitive transcranial magnetic stimulation to the ipsilateral and contralateral auditory cortex in unilateral tinnitus. Electromagn Biol Med. 2014 Sep;33(3):211-5. doi: 10.3109/15368378.2013.801353. Epub 2013 Jun 19.
PubMed 23781982Kleinjung T, Eichhammer P, Landgrebe M, Sand P, Hajak G, Steffens T, Strutz J, Langguth B. Combined temporal and prefrontal transcranial magnetic stimulation for tinnitus treatment: a pilot study. Otolaryngol Head Neck Surg. 2008 Apr;138(4):497-501. doi: 10.1016/j.otohns.2007.12.022.
PubMed 18359361Kreuzer PM, Landgrebe M, Schecklmann M, Poeppl TB, Vielsmeier V, Hajak G, Kleinjung T, Langguth B. Can Temporal Repetitive Transcranial Magnetic Stimulation be Enhanced by Targeting Affective Components of Tinnitus with Frontal rTMS? A Randomized Controlled Pilot Trial. Front Syst Neurosci. 2011 Nov 4;5:88. doi: 10.3389/fnsys.2011.00088. eCollection 2011.
PubMed 22069382De Ridder D, Song JJ, Vanneste S. Frontal cortex TMS for tinnitus. Brain Stimul. 2013 May;6(3):355-62. doi: 10.1016/j.brs.2012.07.002. Epub 2012 Jul 24.
PubMed 22853891Lehner A, Schecklmann M, Kreuzer PM, Poeppl TB, Rupprecht R, Langguth B. Comparing single-site with multisite rTMS for the treatment of chronic tinnitus - clinical effects and neuroscientific insights: study protocol for a randomized controlled trial. Trials. 2013 Aug 23;14:269. doi: 10.1186/1745-6215-14-269.
PubMed 23968498Lehner A, Schecklmann M, Poeppl TB, Kreuzer PM, Vielsmeier V, Rupprecht R, Landgrebe M, Langguth B. Multisite rTMS for the treatment of chronic tinnitus: stimulation of the cortical tinnitus network--a pilot study. Brain Topogr. 2013 Jul;26(3):501-10. doi: 10.1007/s10548-012-0268-4. Epub 2012 Dec 11.
PubMed 23229756Langguth B, Landgrebe M, Frank E, Schecklmann M, Sand PG, Vielsmeier V, Hajak G, Kleinjung T. Efficacy of different protocols of transcranial magnetic stimulation for the treatment of tinnitus: Pooled analysis of two randomized controlled studies. World J Biol Psychiatry. 2014 May;15(4):276-85. doi: 10.3109/15622975.2012.708438. Epub 2012 Aug 22.
PubMed 22909265Hoekstra CE, Versnel H, Neggers SF, Niesten ME, van Zanten GA. Bilateral low-frequency repetitive transcranial magnetic stimulation of the auditory cortex in tinnitus patients is not effective: a randomised controlled trial. Audiol Neurootol. 2013;18(6):362-73. doi: 10.1159/000354977. Epub 2013 Oct 19.
PubMed 24157459Engelhardt J, Dauman R, Arne P, Allard M, Dauman N, Branchard O, Perez P, Germain C, Caire F, Bonnard D, Cuny E. Effect of chronic cortical stimulation on chronic severe tinnitus: a prospective randomized double-blind cross-over trial and long-term follow up. Brain Stimul. 2014 Sep-Oct;7(5):694-700. doi: 10.1016/j.brs.2014.05.008. Epub 2014 Jun 4.
PubMed 25017670Plewnia C, Vonthein R, Wasserka B, Arfeller C, Naumann A, Schraven SP, Plontke SK. Treatment of chronic tinnitus with theta burst stimulation: a randomized controlled trial. Neurology. 2012 May 22;78(21):1628-34. doi: 10.1212/WNL.0b013e3182574ef9. Epub 2012 Apr 25.
PubMed 22539568Roland LT, Peelle JE, Kallogjeri D, Nicklaus J, Piccirillo JF. The effect of noninvasive brain stimulation on neural connectivity in Tinnitus: A randomized trial. Laryngoscope. 2016 May;126(5):1201-6. doi: 10.1002/lary.25650. Epub 2015 Sep 30.
PubMed 26422238Kleinjung T, Steffens T, Sand P, Murthum T, Hajak G, Strutz J, Langguth B, Eichhammer P. Which tinnitus patients benefit from transcranial magnetic stimulation? Otolaryngol Head Neck Surg. 2007 Oct;137(4):589-95. doi: 10.1016/j.otohns.2006.12.007.
PubMed 17903575
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation for Chronic Subjective Non-Pulsatile Primary Tinnitus Compared to Placebo and Medicament Therapy
- ClinicalTrials.gov ID
- NCT03425045
- Acronym / sponsor ID
- FNO-ENT-tinnitus
- Conditions
- Tinnitus, Subjective
- Keywords
- chronic tinnitus, repetitive transcranial magnetic stimulation, hypacusion, depression, treatment, placebo, medication therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Therapy of subjective chronic primary tinnitus could be challenging. Repetitive transcranial magnetic stimulation (rTMS) is currently being tested for suppressing the symptoms. However, effect of stimulation remains controversial. The aim was to uncover real effect of rTMS stimulation for tinnitus treatment. There will be three groups, stimulation group, sham stimulation group and controlled group with medicament treatment. The investigators assume that combination of rTMS stimulation of dorsolateral prefrontal cortex and primary auditory cortex at both sides will be more efficient. The investigators considered a 10% improvement in the tinnitus questionnaire score and in the tinnitus masking to be clinically relevant.
Detailed description
Adult patients suffering from chronic subjective non-pulsatile primary unilateral or bilateral tinnitus for at least 6 months will be included in the study. Patients will be randomly assigned using a random number generation randomization method into rTMS stimulation group (group 1), sham stimulation group (group 2) and group with medicament therapy only (group 3). Dorsolateral prefrontal cortex (frequency 25 Hz; 300 pulses; 80% resting motor threshold=RMT) and primary auditory cortex on both sides (1 Hz; 1000 pulses; 110% RMT) will be stimulated in patients in rTMS stimulation group for 5 consecutive days. Both the patients and outcome assessor were blinded to the intervention group in which the patients (rTMS and shame stimulation group) belonged to. Medicament therapy in group 3 will consist of ginkgo biloba extract EGb 761 once a day for 6 months. There will be no medicament therapy for tinnitus in group 1 and 2. Tinnitus reaction questionnaire (TRQ), tinnitus handicap questionnaire (THQ), tinnitus handicap inventory (THI), Beck Depression Inventory (BDI), pure-tone audiometry with Fowler scoring of hearing loss and tinnitus analysis will be used for evaluation of tinnitus in all patients. Data will be recorded on the day patient is included in the study, during follow-up after 1 month and 6 months. Descriptive statistics, such as the arithmetic mean, standard deviation, and absolute and relative frequency tables, will be used for data processing. The Pearson's chi-squared test, Fisher's exact test, Kruskal-Wallis test and analysis of variance will be used for comparison. The statistical tests will be assessed using a significance level of 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The study is designed as interventional, blinded, randomized, controlled trial with three parallel arms
| Arm | Type | Receives |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | Experimental | Procedure: Repetitive Transcranial Magnetic StimulationPatients in this study arm will undergo the rTMS stimulation as described above. |
| Sham stimulation | Sham comparator | Procedure: Sham stimulationPatients in this study arm will undergo the sham stimulation as described above. |
| Ginkgo Biloba Extract | Active comparator | Drug: Ginkgo Biloba ExtractPatients in this study arm will receive medication therapy as described above, without any rTMS or sham procedure. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjective chronic non-pulsatile tinnitus lasting more than 6 months
Key exclusion criteria (12 listed)
- head injury or brain surgery
- epilepsy
- organic brain lesion
- Meniere's disease or fluctuating hearing loss
- cochlear or bone-anchored hearing device implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationPatients randomised in Arm 1 will receive stimulation of the dorsolateral prefrontal cortex (frequency 25 Hz; 300 pulses; 80% resting motor threshold=RMT) and primary auditory cortex on both sides (1 Hz; 1000 pulses; 110% RMT) will be stimulated in patients in rTMS stimulation group for 5 consecutive days. No medication therapy will be provided for patients in this arm. | Procedure or surgery | Repetitive Transcranial Magnetic Stimulation |
| Sham stimulationSham stimulation will be performed in patients randomised in Arm 2 of the study for 5 consecutive days. No medication therapy will be provided for patients in this arm. | Procedure or surgery | Sham stimulation |
| Ginkgo Biloba ExtractPatients randomised in Arm 3 of the study will receive medication therapy with Ginkgo biloba extract EGb 761 once a day for 6 months. | Drug | Ginkgo Biloba Extract |
Primary outcome
Tinnitus Reaction Questionnaire (TRQ)
Time frame: 36 months
This questionnaire will be used to find out what sort of effects tinnitus has had on the lifestyle and general well-being of the patients. 10% improvement will be considered clinically relevant.
Tinnitus Handicap Questionnaire (THQ)
Time frame: 36 months
This questionnaire has 27 questions and will be used to assess the degree of handicap that the tinnitus presents for the affected patients. 10% improvement will be considered clinically relevant.
Tinnitus Handicap Inventory (THI)
Time frame: 36 months
The purpose of this questionnaire is to identify difficulties the affected patients may be experiencing because of tinnitus. 10% improvement of the score will be considered clinically relevant.
2 secondary outcomes
Improvement of depression - Beck Depression Inventory
Time frame: 36 months
Improvement of hearing loss - Fowler scoring
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Background: PubMed 17114152Folmer RL, Carroll JR, Rahim A, Shi Y, Hal Martin W. Effects of repetitive transcranial magnetic stimulation (rTMS) on chronic tinnitus. Acta Otolaryngol Suppl. 2006 Dec;(556):96-101. doi: 10.1080/03655230600895465.
- Background: PubMed 21221011Oberman L, Edwards D, Eldaief M, Pascual-Leone A. Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. J Clin Neurophysiol. 2011 Feb;28(1):67-74. doi: 10.1097/WNP.0b013e318205135f.
- Background: PubMed 25034472Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5.
- Background: PubMed 23781982Kim BG, Kim DY, Kim SK, Kim JM, Baek SH, Moon IS. Comparison of the outcomes of repetitive transcranial magnetic stimulation to the ipsilateral and contralateral auditory cortex in unilateral tinnitus. Electromagn Biol Med. 2014 Sep;33(3):211-5. doi: 10.3109/15368378.2013.801353. Epub 2013 Jun 19.
- Background: PubMed 18359361Kleinjung T, Eichhammer P, Landgrebe M, Sand P, Hajak G, Steffens T, Strutz J, Langguth B. Combined temporal and prefrontal transcranial magnetic stimulation for tinnitus treatment: a pilot study. Otolaryngol Head Neck Surg. 2008 Apr;138(4):497-501. doi: 10.1016/j.otohns.2007.12.022.
- Background: PubMed 22069382Kreuzer PM, Landgrebe M, Schecklmann M, Poeppl TB, Vielsmeier V, Hajak G, Kleinjung T, Langguth B. Can Temporal Repetitive Transcranial Magnetic Stimulation be Enhanced by Targeting Affective Components of Tinnitus with Frontal rTMS? A Randomized Controlled Pilot Trial. Front Syst Neurosci. 2011 Nov 4;5:88. doi: 10.3389/fnsys.2011.00088. eCollection 2011.
- Background: PubMed 22853891De Ridder D, Song JJ, Vanneste S. Frontal cortex TMS for tinnitus. Brain Stimul. 2013 May;6(3):355-62. doi: 10.1016/j.brs.2012.07.002. Epub 2012 Jul 24.
- Background: PubMed 23968498Lehner A, Schecklmann M, Kreuzer PM, Poeppl TB, Rupprecht R, Langguth B. Comparing single-site with multisite rTMS for the treatment of chronic tinnitus - clinical effects and neuroscientific insights: study protocol for a randomized controlled trial. Trials. 2013 Aug 23;14:269. doi: 10.1186/1745-6215-14-269.
- Background: PubMed 23229756Lehner A, Schecklmann M, Poeppl TB, Kreuzer PM, Vielsmeier V, Rupprecht R, Landgrebe M, Langguth B. Multisite rTMS for the treatment of chronic tinnitus: stimulation of the cortical tinnitus network--a pilot study. Brain Topogr. 2013 Jul;26(3):501-10. doi: 10.1007/s10548-012-0268-4. Epub 2012 Dec 11.
- Background: PubMed 22909265Langguth B, Landgrebe M, Frank E, Schecklmann M, Sand PG, Vielsmeier V, Hajak G, Kleinjung T. Efficacy of different protocols of transcranial magnetic stimulation for the treatment of tinnitus: Pooled analysis of two randomized controlled studies. World J Biol Psychiatry. 2014 May;15(4):276-85. doi: 10.3109/15622975.2012.708438. Epub 2012 Aug 22.
- Background: PubMed 24157459Hoekstra CE, Versnel H, Neggers SF, Niesten ME, van Zanten GA. Bilateral low-frequency repetitive transcranial magnetic stimulation of the auditory cortex in tinnitus patients is not effective: a randomised controlled trial. Audiol Neurootol. 2013;18(6):362-73. doi: 10.1159/000354977. Epub 2013 Oct 19.
- Background: PubMed 25017670Engelhardt J, Dauman R, Arne P, Allard M, Dauman N, Branchard O, Perez P, Germain C, Caire F, Bonnard D, Cuny E. Effect of chronic cortical stimulation on chronic severe tinnitus: a prospective randomized double-blind cross-over trial and long-term follow up. Brain Stimul. 2014 Sep-Oct;7(5):694-700. doi: 10.1016/j.brs.2014.05.008. Epub 2014 Jun 4.
- The American Academy of Audiology is the world's largest professional organization of, by, and for audiologists.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The plan to share IPD to other researchers has not been decided yet.
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COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY
Somatosensory Tinnitus, Subjektif tınnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal Bar, Ass.Prof.,MD,PhD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation and Ginkgo Biloba Extract in people with Tinnitus, Subjective, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Reaction Questionnaire (TRQ) (time frame: 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03425045, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.